LAVAL, QC, March 13, 2019 /CNW Telbec/ - Servier Canada is pleased to announce that LIXIANA® is now reimbursed by the Régie de l'assurance maladie du Québec (RAMQ†) under the Exception Drug Status process for patients with atrial fibrillation or venous thromboembolism. Quebec joins Alberta, where LIXIANA® has been covered since March 1, as the second province to reimburse LIXIANA®.
The RAMQ reimbursement criteria for LIXIANA® are as follows:
- prevention of stroke and systemic embolic event in persons with non-valvular atrial fibrillation requiring anticoagulant therapy.
- treatment of persons with a venous thromboembolism (deep vein thrombosis or pulmonary embolism). Authorization Period : 12 months.
Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting approximately 350,000 Canadians. The risk of developing atrial fibrillation increases with age and with other risk factors such as diabetes, high blood pressure and underlying heart disease. Untreated atrial fibrillation puts patients at a higher risk for stroke and heart failure. People with atrial fibrillation have 3 to 6 times greater risk for ischemic stroke.i For the vast majority of people with atrial fibrillation, an oral anticoagulant is recommended to lower this high risk of stroke. ii
"There is an added value to offering atrial fibrillation patients a once‑daily oral anticoagulant for the prevention of stroke, without having to consider diet," said Jean Champagne, MD, FRCPC, Cardiologist and Electrophysiologist, Head of the electrophysiology sector, Quebec Heart and Lung Institute and Clinical Professor, Université Laval.
"I support covering a fourth direct oral anticoagulant in Quebec for the treatment of atrial fibrillation. This will allow us to further personalize the anticoagulant treatment prescribed to our patients and offer what is best for them," said Jean‑François Roux, MD, FRCPC, Cardiologist and Electrophysiologist, Centre Hospitalier Universitaire de Sherbrooke, Professor, Cardiology Department and Director of the Université de Sherbrooke's Core Internal Medicine Program.
Venous thromboembolism (VTE) includes two conditions: deep vein thrombosis (DVT) and pulmonary embolism (PE). A DVT is a blood clot in the leg veins, and a PE is a blood clot that travels to the heart and lung circulation. VTE is diagnosed in 1-2 per 1,000 persons per year. Anticoagulants are the mainstay of VTE treatment; they are very effective at preventing VTE extension and VTE recurrence, with relative risk reductions greater than 80%. iv "Servier is committed to therapeutic progress to serve patients' needs and all of our activities are centered on achieving this objective. We are very pleased with the RAMQ's decision which will ensure that eligible patients with atrial fibrillation or venous thromboembolism have access to LIXIANA®" said Frédéric Fasano, Chief Executive Officer of Servier Canada. "Servier continues to work actively with the other provinces to ensure that patients with atrial fibrillation or venous thromboembolism across Canada will soon have equal access to LIXIANA®."
About LIXIANA® (edoxaban)
Edoxaban is an oral, once-daily, direct factor Xa inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin and less prone to clotting. Its marketing authorisation is based on two pivotal phase III trials which assessed the efficacy and safety of edoxaban in both indications and which represent the largest clinical development programme ever performed in this field. ENGAGE-AF and HOKUSAI-VTE included more than 21,000 and 8,000 patients respectively. iii
About Servier Canada
Servier Canada Inc. is an affiliate of the independent French Servier Group. Our mission is to provide the Canadian medical community and its patients with innovative therapeutic solutions. As such, Servier Canada collaborates with various players in the healthcare system including researchers, entrepreneurs and innovators. In addition to these research partners, the Canadian International Center for Therapeutic Research (ICTR) is dedicated to clinical development with more than 50 studies conducted throughout Canada over the last 10 years. More information is available at www.servier.ca
i What is atrial fibrillation? https://www.heartandstroke.ca, Consulted March 7, 2019.
ii Patient Information Sheet – You have Atrial Fibrillation, https://thrombosiscanada.ca/resourcepage/patient-family-information/
iii LIXIANA® : Product Monograph, July 26, 2017
iv Canvector, https://www.canvector.ca/venous-thromboembolism, Consulted March 7, 2019.
† Official Mark of the Régie de l'assurance maladie du Québec.
¥ Available at : www.ramq.gouv.qc.ca/fr/professionnels/Pages/professionnels.aspx Consulted March 7, 2019.
LIXIANA® is a registered trademark of Daiichi Sankyo Co., Ltd. Used under license.
SOURCE Servier Canada Inc.
For further information: Nadine DOUCET, Servier Canada, (450) 978-9700 ext. 4225, (514) 601-4881, firstname.lastname@example.org